Auditory Training Via Teleconference

Rehabilitation Clinical Trial

Official title:

Evaluation of Teleconferencing in the Provision of Auditory Training Services

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04207866
• Other study ID #: 348-2019
• Status: Recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: January 2025

Study information

• Verified date: May 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: Kaye Dizon, B.Sc.
• Phone: 416-480-6100
• Email: kaye.dizon[@]sri.utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multi-channel cochlear implants have been highly successful in restoring speech understanding to individuals with severe-to-profound hearing loss. Optimal programs facilitate access to sound but do not necessarily result in optimal performance. Practiced listening with auditory inputs is required to retrain the brain to hear using a cochlear implant. In some cases exposure to sound in everyday listening is sufficient; however, in others there is a need for the provision of auditory training (AT) by a trained professional. In these cases it is important to have regular visits with a specialist to: 1) facilitate auditory training exercises; 2) work with the family/friends to encourage optimal communication strategies in the home; 3) evaluate and assess achievement of listening goals. This study seeks to evaluate the feasibility of providing auditory training services remotely for patient populations located outside of Toronto. This study also seeks to evaluate interindividual perspectives regarding access and benefits of these services across remote and in person sessions.

Description:

Individuals with severe-to-profound hearing impairment, who no longer benefit from hearing aids, are candidates for cochlear implantation. In many cases these devices provide access to sound and are successful in restoring speech understanding; however, there are instances where individuals might need additional assistance in the form of auditory training (AT). This study will involve comparison of two groups of individuals. Participants will be randomly assigned to the standard of care group OR the remote care group. Individuals who meet eligibility criteria will be contacted to assess their willingness to participate in additional auditory training (AT) sessions. These sessions will be conducted either face-to-face or via the Ontario Telehealth network as per random assignment. AT sessions will occur over the first 3 months following activation of the cochlear implant. Outcomes will be assessed using performance measures and questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Newly implanted subjects who might need additional auditory training supports (e.g. long-term deafened, limited communication partners etc.)
• Post-lingual onset of hearing loss
• No cognitive deficits
• English must be their native language
• Willingness to use teleconferencing methods to obtain AT services and residing >1 hr away by car from the hospital
• Willingness to attend these appointments with a communication partner wherever possible

Exclusion Criteria:

• Onset of hearing loss prior to two years of age (prelingual hearing loss)
• Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and imaging including MRI
• Hearing loss of retro-cochlear or central origin
• Additional handicaps that would prevent participation in evaluations
• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic device
• Active middle ear infection
• Unwillingness or inability of the candidate to comply with all investigational requirements
• History of radiation
• Patient concerns regarding their own technological skills and ability to use teleconferencing methods

Related Conditions & MeSH terms

• Auditory; Nerve
• Cochlear Implants
• Deafness
• Hearing Impairment, Sensorineural
• Hearing Loss
• Hearing Loss, Sensorineural
• Rehabilitation

Intervention

Other:
• Teleconferencing
Use of video/audio stream to provide auditory training at a remote site.
• Auditory training services
Participants will engage in regular visits with a specialist to: 1) facilitate auditory training exercises; 2) work with the family/friends to encourage optimal communication strategies in the home; 3) evaluate and assess achievement of listening goals. Auditory training assess/reviews skills associated with but not necessarily limited to: 1) developing strategies to repair communication breakdowns; 2) listening in quiet; 3) listening in noise; 4) listening to a degraded signal.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Bush ML, Thompson R, Irungu C, Ayugi J. The Role of Telemedicine in Auditory Rehabilitation: A Systematic Review. Otol Neurotol. 2016 Dec;37(10):1466-1474. Review. — View Citation

Cullington H, Kitterick P, DeBold L, Weal M, Clarke N, Newberry E, Aubert L. Have Cochlear Implant, Won't Have to Travel: Introducing Telemedicine to People Using Cochlear Implants. Am J Audiol. 2016 Oct 1;25(3S):299-302. doi: 10.1044/2016_AJA-16-0018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Teleconferencing for AT Services: In house questionnaire	In house questionnaire assessing benefits of using remote network for provision of services. Questionnaires asks several questions related to quality of audio-visual signal, ease of use, duration of appointments and whether or not the participants outcomes were achieved. Responses are on a likert scale (Strongly agree (1), agree, neutral, disagree, strongly disagree (5)). Higher scores mean a poorer outcome.	2 years
Secondary	Speech performance	A battery of tests is used within the standard of care provided to cochlear implant recipients. These tests are used as a gauge of performance with the device in the real world. The first test is the Arizona Biologic (AzBio) test which is assessed in quiet and at +5 dB SNR. It is scores in percentage of words correct. Higher scores are correlated with better outcomes.	2 years
Secondary	Speech performance	A battery of tests is used within the standard of care provided to cochlear implant recipients. These tests are used as a gauge of performance with the device in the real world. The second test is the Hearing in Noise (HINT) test which is assessed in quiet and at +5 dB SNR. It is scores in percentage of words correct. Higher scores are correlated with better outcomes.	2 years
Secondary	Speech performance	A battery of tests is used within the standard of care provided to cochlear implant recipients. These tests are used as a gauge of performance with the device in the real world. The third test is the Consonant-Nucleus-Consonant (CNC) word test which is assessed in quiet and at +5 dB SNR. It is scores in percentage of words correct. Higher scores are correlated with better outcomes.	2 years
Secondary	Connection reliability of telepractice services	Given that the remote connection can be impacted by power supply etc. a count of signal interference/breakdowns will be made over the course of the study. Different mediums may be used to provide services (e.g. Ontario Telehealth Network, Zoom, Webx) in order to provide support to CI users in a convenient manner for them.	2 years
Secondary	Subjective Perspectives on Auditory Training Benefits	Participants will complete an in-house questionnaire addressing perceived benefits of the services they received as well as an assessment of audiovisual quality, disturbances in the appointment etc. for the teleconferencing group. The questionnaire uses a likert scale using descriptors of agreement (i.e. Strongly agree (1), agree, neutral, disagree, strongly disagree (5)). A higher score indicates poorer outcomes.	2 years
Secondary	Client Oriented Scale of Improvement (COSI)	The COSI is a well recognized subjective questionnaire used to assess pre/post-treatment improvement in listening. It will be used to assess the participants perceived benefit of treatment prior to their first Auditory training appointment and again once they are done receiving these services. It asks the listener to generate up to 5 listening goals. It then uses subjective assessment to assess their improvement as a % of change. Reporting is also completed using a likert scale with descriptors (Worse, No difference, slightly better, better, much better). Higher percentage and greater degree of change are associated with better outcomes.	2 years